Z-0162-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 23, 2017
- Termination Date
- April 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,000 units
Product Description
Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
Reason for Recall
Possible open seal on top portion of the package. Could cause breach of sterility.
Distribution Pattern
Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Internationally to Canada.
Code Information
Model No. MSG1285, Lot No. 701893369485